Trial Information

A Phase lb Trial of the Combination of Bryostatin-1 and Low Dose Interleukin-2: Evaluation of the Functional and Molecular Status of Human Monocytes as Antigen Presenting Cells

OBJECTIVES:

- Determine the safety and side effects of bryostatin 1 and interleukin-2 in patients with refractory solid tumors or lymphomas.

- Determine the maximum tolerated dose for interleukin-2 with bryostatin 1 in these patients.

- Determine whether bryostatin 1 and interleukin-2 increase the expression of recognition and costimulatory molecules on human monocytes and their ability to act as antigen presenting cells.

- Assess any anti-tumor response in these patients treated with this regimen.

OUTLINE: This is a dose escalation study of interleukin-2.

Patients receive bryostatin 1 IV over 24 hours on days 1 and 8, and interleukin-2 subcutaneously on days 1-5 and days 8-12. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of interleukin-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study in less than 2 years.

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically proven solid tumor or lymphoma that is not curable by surgery, radiotherapy, or standard chemotherapy, or for which no curative therapy exists

- Prostate cancer patients must have the following:

- Tumor progression following blockade of both testicular and adrenal androgens

- Serum testosterone in the castrate range (less than 20 ng/mL)

- At least 3 months since prior suramin therapy

- At least 4 weeks since prior flutamide or other antiandrogen medication and no evidence of response to treatment

- Luprolide should continue if no prior orchiectomy

- No prior or concurrent brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0 or 1

Life expectancy:

- At least 3 months

Hematopoietic:

- WBC at least 3,500/mm^3 OR

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 8 g/dL

Hepatic:

- Hepatitis B surface antigen negative

- PT no greater than 14 seconds

- PTT no greater than 35 seconds

- Bilirubin no greater than 1.5 mg/dL unless due to Gilbert's disease

- SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 2.5 times ULN

- Albumin at least 2.5 g/dL

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 50 mL/min

- Corrected calcium at least 8.0 mg/dL, but no greater than 10.7 mg/dL

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